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This bill would ask the Government Accountability Office to study what rules and approval processes make it harder or more expensive to build or expand drug manufacturing plants in the United States. It focuses on whether environmental and other regulations slow projects down, raise costs, or make the U.S. less attractive than other countries for pharmaceutical factories. The goal is to find ways to make it easier to build these facilities at home and strengthen the drug supply chain.
- The study would look at both the time delays and the added costs caused by regulations for new or expanded pharmaceutical plants.
- It would compare U.S. rules with those in other countries to see whether the United States is less competitive as a place to make medicines.
- The report would examine how regulations may affect the stability and resilience of the drug supply chain.
- The study would also suggest actions regulators could take, such as faster reviews, inspections, and approvals, and recommend ways to support new technologies that could help manufacturers meet regulatory requirements more easily.
Official Summaries
Enhancing Domestic Drug Manufacturing Competitiveness Act
This bill requires the Government Accountability Office (GAO) to study and report to Congress on key regulatory barriers to pharmaceutical manufacturing in the United States.
Specifically, GAO must identify and assess, including by engaging stakeholders, barriers that impede expansion or siting of pharmaceutical manufacturing facilities in the United States or make the United States less competitive than other countries as a location for such facilities. GAO must consider (1) whether environmental or other regulations significantly delay and increase the cost of expanding or siting pharmaceutical manufacturing facilities in the United States; (2) the potential impact of environmental and other regulations on pharmaceutical supply chain resiliency; and (3) specific actions for regulators to address the identified barriers.
Finally, the report must include recommendations for streamlining regulatory barriers and facilitating technological solutions to foster U.S. pharmaceutical manufacturing.
Current Full Text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1405 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 1405
To direct the Comptroller General of the United States to conduct a
study to assess the key regulatory barriers that impede the expansion
or siting of new pharmaceutical manufacturing facilities in the United
States, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 18, 2025
Mr. Buchanan (for himself and Mr. Donalds) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To direct the Comptroller General of the United States to conduct a
study to assess the key regulatory barriers that impede the expansion
or siting of new pharmaceutical manufacturing facilities in the United
States, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Enhancing Domestic Drug
Manufacturing Competitiveness Act''.
SEC. 2. STUDY ON KEY REGULATORY BARRIERS TO EXPANDING PHARMACEUTICAL
MANUFACTURING IN THE UNITED STATES.
(a) In General.--The Comptroller General of the United States shall
conduct a study to identify, and to assess on a time and cost basis,
the key regulatory barriers that--
(1) impede the expansion or siting of new pharmaceutical
manufacturing facilities in the United States; or
(2) make the United States less competitive than other
countries as a location for such facilities.
(b) Questions.--In conducting the study under subsection (a), the
Comptroller General shall consider the following questions:
(1) Do environmental or other regulations significantly
delay, and increase the costs for manufacturers of, expanding
or siting pharmaceutical manufacturing facilities in the United
States relative to environmental or other regulations in other
countries?
(2) What is the potential impact of environmental and other
regulations on pharmaceutical supply chain resiliency?
(3) What specific actions (such as expediting reviews,
inspections, and approvals of new facilities or changes to
existing facilities) could be taken by regulators to address
the regulatory barriers described in subsection (a)?
(c) Engaging Stakeholders.--In conducting the study under
subsection (a), the Comptroller General shall engage stakeholders--
(1) to identify and assess the barriers described in
subsection (a);
(2) to identify whether there are promising technological
solutions, including manufacturing processes, that could help
to address the regulatory barriers described in subsection (a);
and
(3) to identify the policies needed to support and foster
any solutions identified pursuant to paragraph (2).
(d) Report.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Comptroller General shall complete
the study under subsection (a) and submit to the Congress a
report on the results of such study.
(2) Contents.--The report required by paragraph (1) shall--
(A) identify, and assess on a time and cost basis,
the regulatory barriers described in subsection (a);
(B) address each question listed in subsection (b);
and
(C) include recommendations for streamlining the
regulatory barriers described in subsection (a), and
facilitating the use of technological solutions
described in subsection (c)(2), to foster increased
pharmaceutical manufacturing in the United States.
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